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Changes Sought in Molecularly Targeted Drug Studies

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Three industry stakeholders recommend that FDA add information to a draft guidance on pediatric studies of molecularly targeted on...

Troubling Pattern to CDRH Missed Deadlines: Attorneys

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Two Hyman, Phelps attorneys see a troubling pattern in deadlines being missed by CDRH.

Only 20 Drugs on Virus Watch, Not 150: Hahn

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FDA commissioner Stephen Hahn says media reports are wrong about the agency monitoring 150 prescription drugs that could be in sho...

4 Steps to Take FDA Into the Future

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Mark McClellan and Ellen Sigal suggest four steps for FDA to take to move into the 2020s.

LeeSar Violating Outsourcing Requirements: FDA

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FDA warns LeeSar about violations in its work producing drugs as an outsourcing facility.

Dual 510(k)/CLIA Waiver Guide

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Federal Register notice: FDA makes available a final guidance entitled Recommendations for Dual 510(k) and CLIA Waiver by Applicat...

Guide on Laparoscopic Power Morcellators Labeling

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Federal Register notice: FDA makes available a draft guidance entitled Product Labeling for Laparoscopic Power Morcellators.

Guide on CLIA Waiver for IVD Devices

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Federal Register notice: FDA makes available a final guidance entitled Recommendations for Clinical Laboratory Improvement Amendme...

CDRH Launches eSTAR 510(k) Pilot

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CDRH launches a pilot of its new eSTAR platform for 510(k) submissions.

4 Observations on Dynalabs FDA-483

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FDA releases the FDA-483 with four observations from an inspection at Dynalabs.